Nycomed US Inc.
MATERIAL SAFETY DATA SHEET
Prepared to U.S. OSHA, CMA, ANSI, and Canadian WHMIS
PART I What is the material and what do I need to know in an emergency?
1. PRODUCT IDENTIFICATION
TRADE NAME/MATERIAL NAME: Betamethasone Dipropionate Lotion 0.05%
Betamethasone Dipropionate Lotion
DESCRIPTION:
0168-0057-60
NDC #:
9-fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-
CHEMICAL NAME (for active ingredient):
diene-3,20-dione 17,21-Dipropionate
Corticosteroid
CHEMICAL FAMILY (for active ingredient):
0.05% Lotion
HOW SUPPLIED:
C28H37FO7
FORMULA (for active ingredient):
Pharmaceutical for Human Use
PRODUCT USE:
SUPPLIER/MANUFACTURER'S NAME: NYCOMED US INC.
60 Baylis Road
ADDRESS:
Melville, NY 11747
1-631-454-7677
BUSINESS PHONE/GENERAL MSDS INFORMATION:
EMERGENCY PHONE (U.S./Canada/Puerto Rico): 1-800-424-9300 (24-hr)
EMERGENCY PHONE (OUTSIDE U.S.): +1-631-454-7677
NOTE: ALL United States Occupational Safety and Health Administration Standard (29 CFR 1910.1200), U.S. State equivalent Standards, and Canadian WHMIS [Controlled
Products Regulations] required information is included in appropriate sections based on the U.S. ANSI Z400.1-2004 format. This product has been classified in accordance
with the hazard criteria of the countries listed above.
2. HAZARD IDENTIFICATION
EMERGENCY OVERVIEW: Product Description: This product is a white, lotion with a mild rubbing alcohol odor.
Health Hazards: Employees administering the product should not experience adverse effects if handled properly. The
chief health hazard associated with exposure during normal use and handling is the potential for irritation of
contaminated skin. Individuals who have had allergic reactions to products containing the active ingredient,
Betamethasone Dipropionate (or any other components of this product) may experience allergic reactions to this
product. Repeated skin exposure to Betamethasone Dipropionate may cause adverse reproductive effects, based on
animal data. Flammability Hazards: This product is flammable. It is readily ignited under ambient conditions.
Vapors from the Isopropyl Alcohol component of this product are heavier than air and may travel to a source of ignition
and flashback to a leak or open container. Reactivity Hazards: This product is not reactive. Environmental
Hazards: This product has not been tested for environmental effects. Emergency Considerations: Emergency
responders should wear appropriate protection for situations to which they respond.
3. COMPOSITION and INFORMATION ON INGREDIENTS
CHEMICAL NAME CAS # % w/w
Betamethasone Dipropionate 5593-20-4 0.05%
Isopropyl Alcohol 67-63-0 Proprietary
Water and other components. Each of the other components is present in less The remaining components do not contribute any significant Balance
additional hazards.
than 1 percent concentration (0.1% concentration for potential carcinogens,
reproductive toxins, respiratory tract sensitizers, and mutagens).
PART II What should I do if a hazardous situation occurs?
4 FIRST-AID MEASURES
Persons developing hypersensitivity reactions should receive medical attention. If breathing is difficult, give oxygen. If
not breathing, give artificial respiration. Take a copy of label and MSDS to physician or health professional with the
contaminated individual.
SKIN EXPOSURE: If adverse skin effects occur, discontinue use. Seek medical attention.
EYE EXPOSURE: If this product contaminates the eyes, rinse eyes under gently running water. Use sufficient force to
open eyelids and then "roll" eyes while flushing. Minimum flushing is for 20 minutes. The contaminated individual must
seek medical attention if any adverse effect continues after rinsing.
INHALATION: If vapors of this product are inhaled, causing irritation, remove victim to fresh air. If necessary, use
artificial respiration to support vital functions.
BETAMETHASONE DIPROPIONATE LOTION 0.05% MSDS EFFECTIVE DATE: SEP 21, 2009
PAGE 1 OF 11
Nycomed US Inc.
4 FIRST-AID MEASURES (Continued)
INGESTION: If this product is swallowed, CALL PHYSICIAN OR POISON CONTROL CENTER FOR MOST CURRENT
INFORMATION. If professional advice is not available, do not induce vomiting. Never induce vomiting or give diluents
(milk or water) to someone who is unconscious, having convulsions, or unable to swallow. If victim is convulsing,
maintain an open airway and obtain immediate medical attention.
MEDICAL CONDITIONS AGGRAVATED BY EXPOSURE: Pre-existing skin conditions may be aggravated by repeated
overexposures to this product.
RECOMMENDATIONS TO PHYSICIANS: This product should only be given to patients by persons experienced in
management of patients receiving the type of therapy intended for this product. Treat symptoms and eliminate
exposure.
5. FIRE-FIGHTING MEASURES
FLASH POINT: 25癈 (77癋) Pensky-Martens Closed Cup
NOTE: The following values have not been determined for the product; NFPA RATING
values given are for the main flammable component, Isopropyl Alcohol. FLAM MAB ILITY
AUTOIGNITION TEMPERATURE: 399癈 (750癋)
FLAMMABLE LIMITS (in air by volume, %):
3
Lower (LEL): 2.0% Upper (UEL): 12.7%
Use extinguishing media
FIRE EXTINGUISHING MATERIALS:
1 0
appropriate for surrounding fire. HEALTH INSTAB ILITY
Water Spray: OK Carbon Dioxide: OK Foam: OK
Dry Chemical: OK Halon: OK Other: Any "ABC" Class
FIRE EXTINGUISHING MATERIALS NOT TO BE USED: None known.
This product is
UNUSUAL FIRE AND EXPLOSION HAZARDS: OTHER
flammable; it can be readily ignited under ambient conditions. When
Hazard Scale: 0 = Minimal 1 = Slight 2 = Moderate
involved in a fire, this material may decompose and produce irritating 3 = Serious 4 = Severe
vapors and toxic compounds (including carbon oxides and hydrogen
fluoride).
Explosion Sensitivity to Mechanical Impact: Not sensitive.
Explosion Sensitivity to Static Discharge: The vapors of this product may be ignited by static electrical energy.
SPECIAL FIRE-FIGHTING PROCEDURES: Incipient fire responders should wear eye protection. Structural
firefighters must wear Self-Contained Breathing Apparatus (SCBA) and full protective equipment. Chemical resistant
clothing may be necessary. If protective equipment is contaminated by this product, it should be thoroughly washed
with running water prior to removal of SCBA respiratory protection. Firefighters whose protective equipment
becomes contaminated should thoroughly shower with warm, soapy water and should receive medical evaluation if
they experience any adverse effects. Move containers from fire area if it can be done without risk to personnel. Water
spray can be used to cool fire-exposed containers. Water fog or spray can also be used by trained firefighters to
disperse this product's vapors and to protect personnel. If possible, prevent runoff water from entering storm drains,
bodies of water, or other environmentally sensitive areas.
6. ACCIDENTAL RELEASE MEASURES
SPILL AND LEAK RESPONSE: Proper protective equipment should be used. In the event of a spill, clear the area
and protect people. Eliminate all sources of ignition before cleanup begins. Use non-sparking tools. Monitor area for
combustible vapor levels to determine level of combustible vapors before personnel are allowed into the spill area. The
atmosphere must have levels of components lower than those listed in Section 8, (Exposure Controls and Personal
Protective Equipment) if applicable, and have at least 19.5 percent oxygen before personnel can be allowed into the
area without Self-Contained Breathing Apparatus (SCBA).
Small Spills: Wear goggles and gloves while wiping up small spills of this product with polypad or sponge.
Large Spills: Trained personnel following pre-planned procedures should handle non-incidental releases. Access to the spill
areas should be restricted. Protective apparel should be used with a respirator when there is any danger of mists or sprays
being generated. Minimum Personal Protective Equipment should be rubber gloves, rubber boots, face shield, and Tyvek suit.
The dispersal of mists or sprays into surrounding air and the possibility of inhalation is a serious matter and should be treated
as such. Minimum level of personal protective equipment for releases in which the level of oxygen is less than 19.5% or is
unknown must be Level B: triple-gloves (rubber gloves and nitrile gloves over latex gloves), chemical resistant suit and
boots, hard hat, and Self-Contained Breathing Apparatus. Absorb spilled liquid using polypads or other suitable absorbent
material. Prevent material from entering sewer or confined spaces, waterways, soil or public waters. Monitor area and confirm
levels are bellow exposure limits given in Section 8 (Exposure Controls-Personal Protection), if applicable, before non-response
personnel are allowed into the spill area.
Decontaminate the area of the spill thoroughly using detergent and water. Place all spill residue in an appropriate
container and seal. Dispose of in accordance with applicable Federal, State, and local procedures (see Section 13,
Disposal Considerations).
BETAMETHASONE DIPROPIONATE LOTION 0.05% MSDS EFFECTIVE DATE: SEP 21, 2009
PAGE 2 OF 11
Nycomed US Inc.
PART III How can I prevent hazardous situations from occurring?
7. HANDLING and USE
WORK PRACTICES AND HYGIENE PRACTICES: As with all chemicals, avoid getting this product ON YOU or IN
YOU. Do not eat, drink, smoke, or apply cosmetics while handling this product. Wash hands thoroughly after
handling this product or equipment and containers that contain this product. Follow SPECIFIC USE INSTRUCTIONS
supplied with this product. Particular care in working with this product must be practiced in pharmacies and other
preparation areas, during manufacture of this product, and during patient administration.
STORAGE AND HANDLING PRACTICES: Employees must be trained to properly use this product. Keep away from
heat, sparks, and other sources of ignition. Use non-sparking tools. Use of this product should be performed in a
designated area for working with drugs. Ensure product is properly labeled. Store this product away from
incompatible materials. Store this product in original container. Storage areas should be made of fire resistant
materials. Post warning and "NO SMOKING" signs in storage and use areas, as appropriate. Have appropriate
extinguishing equipment in the storage area (i.e., sprinkler system, portable fire extinguishers). Empty packages may
contain residual liquid or vapors that are flammable; therefore, empty packages should be handled with care. Refer to
NFPA 30, Flammable and Combustible Liquids Code, for additional information on storage.
PRODUCT PREPARATION INSTRUCTIONS FOR MEDICAL PERSONNEL: Handle this material following standard
medical practices and following the recommendations presented on the Package Insert.
SPECIFIC USE(S): This product is a human pharmaceutical. Follow all industry standards for use of this product.
PROTECTIVE PRACTICES DURING MAINTENANCE OF CONTAMINATED EQUIPMENT: When cleaning non-
disposable equipment, wear latex or butyl rubber (double gloving is recommended), goggles, and lab coat. Wash
equipment with soap and water. Wipe equipment down with damp sponge or polypad. Collect all rinsates and dispose
of according to applicable U.S. Federal, State, and local hazardous waste disposal regulations or waste disposal
regulations of Canada. All disposable items contaminated with this product should be disposed of properly.
8. EXPOSURE CONTROLS - PERSONAL PROTECTION
VENTILATION AND ENGINEERING CONTROLS: Use with adequate ventilation. Follow standard medical product
handling procedures. During decontamination of work surfaces, workers should wear the same equipment
recommended in Section 6 (Accidental Release Measures) of this MSDS.
EXPOSURE LIMITS/GUIDELINES:
CHEMICAL NAME CAS # EXPOSURE LIMITS IN AIR
ACGIH-TLVs OSHA-PELs NIOSH-RELs NIOSH OTHER
TWA STEL TWA STEL TWA STEL IDLH
mg/m3 mg/m3 mg/m3 mg/m3 mg/m3 mg/m3 mg/m3 mg/m3
Betamethasone Dipropionate 5593-20-4 NE NE NE NE NE NE NE NE
DFG MAK:
Isopropyl Alcohol 67-63-0 492 984 980 1225 980 1225 4920
TWA = 500
(vacated
PEAK = 2稭AK 15 min., average
1989 PEL)
value, 1 hour interval, 4 per shift
Pregnancy Risk Group
Classification: C
NE = Not Established. See Section 16 for Definitions of Terms Used.
The following information on appropriate Personal Protective Equipment is provided to assist employers in complying with OSHA
regulations found in 29 CFR Subpart I (beginning at 1910.132) or equivalent standards of Canada (including CSA Standard Z94.4-
02 and CSA Standard Z94.3-07). Please reference applicable regulations and standards for relevant details.
RESPIRATORY PROTECTION: A respirator is not required for routine conditions of use of this product. If respiratory
protection is needed, use only respiratory protection authorized in the U.S. Federal OSHA Respiratory Protection
Standard (29 CFR 1910.134), equivalent U.S. State standards, or Canadian CSA Standard Z94.4-02. Oxygen levels
below 19.5% are considered IDLH by OSHA. In such atmospheres, use of a full-facepiece pressure/demand SCBA or
a full facepiece, supplied air respirator with auxiliary self-contained air supply is required under OSHA's Respiratory
Protection Standard (1910.134-1998).
EYE PROTECTION: Not normally needed during normal use. If necessary, refer to U.S. OSHA 29 CFR 1910.133 or
Canadian CSA Standard Z94.3-07.
HAND PROTECTION: For situations in which prolonged skin contact is anticipated, double glove, using latex, nitrile,
or rubber gloves. Check gloves for leaks. Wash hands before putting on gloves and after removing gloves. Gloves
should cover the gown cuff. If necessary, refer to U.S. OSHA 29 CFR 1910.138 or appropriate standards of Canada.
BODY PROTECTION: During patient administration, use of lightweight cotton gown or other medical attire is
recommended. If a hazard of injury to the feet exists due to falling objects, rolling objects, where objects may pierce the
soles of the feet or where employee's feet may be exposed to electrical hazards, use foot protection, as described in
U.S. OSHA 29 CFR 1910.136 and the Canadian CSA Standard Z195-02, Protective Footwear.
BETAMETHASONE DIPROPIONATE LOTION 0.05% MSDS EFFECTIVE DATE: SEP 21, 2009
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Nycomed US Inc.
9. PHYSICAL and CHEMICAL PROPERTIES
BOILING POINT: 80-85癈 (176-185癋) FREEZING/MELTING POINT: 40-50癈 (100-122癋)
EVAPORATION RATE (nBuAc = 1): 0.02 SOLUBILITY IN WATER: Soluble.
VAPOR PRESSURE (air = 1): Not established. SPECIFIC GRAVITY (water = 1): < 1
ODOR THRESHOLD: Not established. pH: 4-6 (10% in Water)
COEFFICIENT WATER/OIL DISTRIBUTION: Not established.
APPEARANCE AND COLOR: This product is a white, lotion with a mild rubbing alcohol odor.
HOW TO DETECT THIS SUBSTANCE (warning properties): The appearance of this product can be a distinguishing
characteristic to identify it in event of accidental release.
10. STABILITY and REACTIVITY
STABILITY: This product is stable.
DECOMPOSITION PRODUCTS: Combustion: If exposed to extremely high temperatures, thermal decomposition may
generate irritating fumes and toxic gases (e.g., carbon oxides and hydrogen fluoride). Hydrolysis: None known.
MATERIALS WITH WHICH SUBSTANCE IS INCOMPATIBLE: This product is generally compatible with other
common materials in a medical facility. Acids, caustics, and other chemicals that could affect its performance should
be avoided.
HAZARDOUS POLYMERIZATION: Will not occur.
CONDITIONS TO AVOID: Avoid heat, light, and contact with incompatible chemicals.
PART IV Is there any other useful information about this material?
11. TOXICOLOGICAL INFORMATION
SYMPTOMS OF OVEREXPOSURE BY ROUTE OF EXPOSURE:
The health hazard information provided below is pertinent to medical HAZARDOUS MATERIAL IDENTIFICATION SYSTEM
employees handling this product in an occupational setting. This
product is designed for application on the skin. The following
paragraphs describe the symptoms of exposure by route of exposure. (BLUE) 1
HEALTH HAZARD
INHALATION: Inhalation of vapors of this product, especially in a
poorly ventilated space, may cause flushing, decreased pulse rate,
drop in blood pressure, numbness, narcosis, headache, dizziness,
mental depression, hallucinations, distorted perception, difficulty
FLAMMABILITY HAZARD (RED) 3
breathing, respiratory depression, nausea, vomiting, and coma.
CONTACT WITH SKIN or EYES: Skin contact may cause burning
sensation, stinging, prickling, itching, and tingling. Corticosteroids
(such as Betamethasone Dipropionate) may cause allergic contact
PHYSICAL HAZARD (YELLOW) 0
dermatitis. This is usually diagnosed by observing a failure to heal
rather than a clinical exacerbation. Eye contact can cause irritation,
stinging, redness, and tearing.
SKIN ABSORPTION: The Betamethasone Dipropionate component PROTECTIVE EQUIPMENT
of this product can be absorbed through intact skin. Symptoms of
chronic overexposure by this route may include reversible EYES HANDS BODY
RESPIRATORY
hypothalamic-pituitaryadrenal (HPA) axis suppression, abnormal
accumulations of facial and trunk fat, fatigue, high blood pressure,
osteoporosis, abnormally high level of glucose in the blood, and S SE
EE CTION 8 SE SEC
E TION 8
abnormally high levels of glucose in the urine.
INGESTION: Ingestion is not a significant route of occupational For Routine Industrial Use and Handling Applications
overexposure. Acute ingestion of large quantities of this product or
chronic ingestion caused by poor hygiene practices may cause Hazard Scale: 0 = Minimal 1 = Slight 2 = Moderate
adverse symptoms. Symptoms of ingestion overexposure may 3 = Serious 4 = Severe * = Chronic hazard
include nausea, vomiting, and diarrhea. Symptoms of ingestion
overexposure may include nausea, vomiting, diarrhea, and respiratory distress. Ingestion can also cause symptoms as
described under "Inhalation".
INJECTION: Though not anticipated to be a significant route of exposure for this product, injection (via punctures or
lacerations by contaminated objects) may cause redness at the site of injection. Symptoms may include those
described for "Other Potential Health Effects".
GENERAL TOXICITY INFORMATION: Individuals who have had allergic reactions to products containing the
Betamethasone Dipropionate component of this product or any other components of this product may experience
allergic reactions to this product.
BETAMETHASONE DIPROPIONATE LOTION 0.05% MSDS EFFECTIVE DATE: SEP 21, 2009
PAGE 4 OF 11
Nycomed US Inc.
11. TOXICOLOGICAL INFORMATION (Continued)
GENERAL TOXICITY INFORMATION (continued): Symptoms described in patients given therapeutic doses of this
substance include the following.
For Males and Females: Persons using the product in therapeutic doses may experience stinging, elevated dark red blotches on
the skin, bruising, skin shininess, burning, itching, irritation, dryness, inflammation of hair follicles, excessive hair growth, acne-
form eruptions, diminished pigmentation, dermatitis around the mouth, allergic contact dermatitis, softening of the skin,
secondary infections, striae, and prickly heat.
IRRITANCY OF PRODUCT: This product may mildly to moderately irritate contaminated tissue.
SENSITIZATION OF PRODUCT: Corticosteroids (such as Betamethasone Dipropionate) may cause allergic contact
dermatitis.
HEALTH EFFECTS OR RISKS FROM EXPOSURE: An Explanation in Lay Terms. Overexposure to this product may
cause the following health effects:
Acute: The primary health effects that may be experienced by medical personnel exposed to this product is mild irritation of
contaminated skin. Accidental ingestion may be harmful. Inhalation of vapors in a poorly ventilated space can cause central
nervous system effects. Eye contact will cause irritation.
Chronic: Corticosteroids (such as Betamethasone Dipropionate) may cause allergic contact dermatitis. Symptoms of chronic skin
absorption exposure may include reversible hypothalamic-pituitaryadrenal (HPA) axis suppression, abnormal accumulations of
facial and trunk fat, fatigue, high blood pressure, osteoporosis, abnormally high level of glucose in the blood, and abnormally
high levels of glucose in the urine.
TARGET ORGANS:
Acute: Occupational Exposure: Skin, central nervous system. Therapeutic Doses: Skin.
Chronic: Occupational Exposure: Skin. Therapeutic Doses: Skin, endocrine system.
TOXICITY DATA: The toxicity data available for the active component of this product, Betamethasone Dipropionate, are
presented in this MSDS. Additional data are available for the excipient components of this product, but are not
presented in this MSDS; Contact Nycomed US Inc. for more information.
BETAMETHASONE DIPROPIONATE: BETAMETHASONE DIPROPIONATE (continued): BETAMETHASONE DIPROPIONATE (continued):
LD50 (Oral-rat) > 4 g/kg TDLo (Subcutaneous-rat) 120 mg/kg/female 9?4 days TDLo (Subcutaneous-rabbit) 6 礸/kg/female 15 days
LD50 (Oral-mouse) > 5 g/kg; Behavioral: antipsychotic; after conception; Reproductive - Effects on Fetus: after conception; Reproductive: Fertility: litter size
Skin and Appendages: hair fetotoxicity (except death, e.g., stunted fetus) (e.g. # fetuses per litter; measured before birth)
LD50 (Intraperitoneal-rat) > 4 g/kg TDLo (Subcutaneous-rat) 480 mg/kg/female 9?4 days TDLo (Subcutaneous-rabbit) 130 礸/kg/female 6-18
LD50 (Intraperitoneal-mouse) 103 mg/kg after conception; Reproductive: Specific days after conception; Reproductive: Fertility: post-
LD50 (Subcutaneous-rat) > 4 g/kg Developmental Abnormalities: urogenital system implantation mortality (e.g. dead and/or resorbed
LD50 (Subcutaneous-mouse) 78100 礸/kg TDLo (Subcutaneous-mouse) 936 礸/kg/female 7?2 implants per total number of implants); Specific
TDLo (skin-rat) 58240 礸/kg/13 weeks/intermittent: days after conception; Reproductive: Effects on Developmental Abnormalities: Central Nervous
Endocrine: changes in spleen weight; Blood: changes Newborn: stillbirth, weaning or lactation index (e.g., # System, eye/ear
in erythrocyte (RBC) count; Nutritional and Gross alive at weaning per # alive at day 4), growth statistics TDLo (Subcutaneous-rabbit) 6 礸/kg/female 15 days
Metabolic: weight loss or decreased weight gain (e.g.%, reduced weight gain) after conception; Reproductive: Fertility: litter size
TDLo (Subcutaneous-rat) 15600 礸/kg/26 TDLo (Subcutaneous mouse) 3750 礸/kg/female 7?2 (e.g. # fetuses per litter; measured before birth)
weeks/intermittent: Endocrine: changes in spleen days after conception; Reproductive: Fertility: post- TDLo (Subcutaneous-rabbit) 130 礸/kg/female 6-18
weight; Blood: changes in erythrocyte (RBC) count, implantation mortality (e.g. dead and/or resorbed days after conception; Reproductive: Fertility: post-
changes in leukocyte (WBC) count implants per total number of implants); Effects on implantation mortality (e.g. dead and/or resorbed
TDLo (Subcutaneous-rat) 910 礸/kg/male 26 weeks pre- Embryo or Fetus: fetal death, other effects to embryo implants per total number of implants); Specific
mating; Reproductive: Paternal Effects: prostate, TDLo (Subcutaneous-mouse) 640 礸/kg/female 12 days Developmental Abnormalities: Central Nervous
seminal vesicle, Cowper's gland, accessory glands after conception; Reproductive: Specific System, eye/ear
TDLo (Subcutaneous-rat) 30 mg/kg/female 9?4 days Developmental Abnormalities: craniofacial (including TDLo (Subcutaneous-rabbit) 12 礸/kg/female 15 days
after conception; Reproductive: Effects on Newborn: nose and tongue) after conception; Reproductive: Specific
stillbirth, weaning or lactation index (e.g., # alive at TDLo (Subcutaneous-mouse) 120 礸/kg/female 7?2 Developmental Abnormalities: craniofacial (including
weaning per # alive at day 4) days after conception; Reproductive: Effects on nose and tongue)
TDLo (Subcutaneous-rat) 7500 礸/kg/female 9?4 days Fetus: fetotoxicity (except death, e.g., stunted fetus) TDLo (Subcutaneous-rabbit) 32500 ng/kg/female 6-18
after conception; Reproductive: Specific TDLo (Subcutaneous-rabbit) 10 礸/kg/female 24 days days after conception; Reproductive: Effects on
Developmental Abnormalities: endocrine system; after conception; Reproductive: Specific Fetus: fetotoxicity (except death, e.g., stunted fetus);
Effects on Newborn: growth statistics (e.g.%, reduced Developmental Abnormalities: endocrine system Specific Developmental Abnormalities:
weight gain) musculoskeletal system
CARCINOGENIC POTENTIAL: Long-term animal studies have not been performed to evaluate the carcinogenic
potential of topical corticosteroids. The incipient components of this product are listed by agencies tracking the
carcinogenic potential of chemical compounds, as follows:
ISOPROPYL ALCOHOL: IARC-3 (Not Classifiable as to Carcinogenicity to Humans); ACGIH-TLV-A4 C (Not Classifiable as a Human Carcinogen)
The remaining components of this product are not found on the following lists: U.S. EPA, U.S. NTP, U.S. OSHA, U.S.
NIOSH, GERMAN MAK, IARC, or ACGIH and therefore are neither considered to be nor suspected to be cancer-
causing agents by these agencies.
REPRODUCTIVE TOXICITY INFORMATION: The active component of this product, Betamethasone Dipropionate, is
rated as Pregnancy Category C (RISK CANNOT BE RULED OUT; Human evidence is lacking, but animal evidence
is positive.). Listed below is information concerning the effects of this product and its components on animal or
human reproductive systems.
Mutagenicity: Betamethasone was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal in the
in vivo mouse bone marrow micronucleus assay. It was negative in the bacterial mutagenicity assay (Salmonella typhimurium
and Escherichia coli), and in the mammalian cell mutagenicity assay (CHO/HGPRT).
Embryotoxicity: Animal studies have not been performed to evaluate the embryotoxicity of Betamethasone Dipropionate. No
human data are available.
BETAMETHASONE DIPROPIONATE LOTION 0.05% MSDS EFFECTIVE DATE: SEP 21, 2009
PAGE 5 OF 11
Nycomed US Inc.
11. TOXICOLOGICAL INFORMATION (Continued)
REPRODUCTIVE TOXICITY INFORMATION (continued):
Teratogenicity: Betamethasone Dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route
at doses of 0.05 mg/kg. This dose is approximately 0.2 fold the maximum human dose based on a mg/m2 comparison. The
abnormalities observed included umbilical hernias, cephalocele, and cleft palates. Some corticosteroids have been shown to be
teratogenic after dermal application in laboratory animals. No human data are available.
Reproductive Toxicity: Reproductive studies with Betamethasone Dipropionate carried out in rabbits at doses of 1.0 mg/kg by the
intramuscular route and in mice up to 33 mg/kg by the intramuscular route indicated no impairment of fertility except for dose-
related increases in fetal resorption rates in both species. These does are approximately 5 and 38 fold the human dose based
on a mg/m2 comparison, respectively. No human data are available.
A mutagen is a chemical that causes permanent changes to genetic material (DNA) such that the changes will propagate through generation lines. An
embryo toxin is a chemical that causes damage to a developing embryo (i.e. within the first eight weeks of pregnancy in humans), but the damage
does not propagate across generational lines. A teratogen is a chemical that causes damage to a developing fetus, but the damage does not
propagate across generational lines. A reproductive toxin is any substance that interferes in any way with the reproductive process.
ACGIH BIOLOGICAL EXPOSURE INDICES (BEIs): Currently, ACGIH Biological Exposure Indices (BEIs) have been
determined for components of this product.
CHEMICAL: SAMPLING TIME BEI
DETERMINANT
Isopropyl Alcohol
?Acetone in urine ?End of Shift End of Workweek ?40 mg/L
12. ECOLOGICAL INFORMATION
ALL WORK PRACTICES MUST BE AIMED AT ELIMINATING ENVIRONMENTAL CONTAMINATION.
ENVIRONMENTAL STABILITY: The components of this product will slowly degrade in the environment and form a
variety of organic materials. Additional information on components of this product are available as follows:
ISOPROPYL ALCOHOL:
Persistence and Biodegradability: Based on a classification scheme, an estimated Koc value of 25, determined from a log Kow of 0.05 and a regression-derived equation, indicates
that Isopropanol is expected to have very high mobility in soil. Volatilization of Isopropanol from moist soil surfaces is expected to be an important fate process given a Henry's
Law constant of 8.10X10-6 atm-cu m/mole. The potential for volatilization of Isopropanol from dry soil surfaces may exist based upon a vapor pressure of 45.4 mmHg.
Isopropanol is readily degraded in aerobic systems; the range of half-lives for aerobic degradation using a sewage sludge inoculum are < 1 day to 48 days. Isopropanol has also
been shown to be readily degraded under anaerobic conditions. Volatilization from water surfaces is expected based upon a Henry's Law constant of 8.10X10-6 atm-cu m/mole.
Using this Henry's Law constant and an estimation method, volatilization half-lives for a model river and model lake are 57 hours and 29 days, respectively. Isopropanol is readily
degraded in aerobic systems; the range of half-lives for aerobic degradation using a sewage sludge inoculum are < 1 day to 48 days. Isopropanol has also been shown to be
readily degraded under anaerobic conditions. According to a model of gas/particle partitioning of semi-volatile organic compounds in the atmosphere, Isopropanol, which has a
vapor pressure of 45.4 mm Hg at 25癈, is expected to exist solely as a vapor in the ambient atmosphere. Vapor-phase Isopropanol is degraded in the atmosphere by reaction
with photochemically-produced hydroxyl radicals; the half-life for this reaction in air is estimated to be 3.2 days, calculated from its rate constant of 5.07X10-12 cu cm/molecule-
sec at 25癈.
Bioconcentration: An estimated BCF of 3 was calculated for Isopropanol, using a log Kow of 0.05 and a regression-derived equation. According to a classification scheme, this
BCF suggests the potential for bioconcentration in aquatic organisms is low.
Soil Adsorption/Mobility: The Koc of Isopropanol is estimated as 25, using a measured log Kow of 0.05 and a regression-derived equation. According to a classification scheme,
this estimated Koc value suggests that Isopropanol is expected to have very high mobility in soil.
EFFECT OF MATERIAL ON PLANTS or ANIMALS: No specific information is currently available on the effect of this
product on plants or animals in the environment. This product may be harmful to contaminated plant and animal life,
especially in large quantities.
EFFECT OF CHEMICAL ON AQUATIC LIFE: Release of this product to an aquatic environment may be harmful to
aquatic plant and animal life in contaminated bodies of water, especially in large quantities. Additional aquatic toxicity
data on components of this product are available as follows:
ISOPROPYL ALCOHOL: ISOPROPYL ALCOHOL (continued):
EC0 (Microcystis aeruginosa) 8 days = 1,000 mg/L LC50 (Daphnia magna) 24 hours = 9,500 mg/L
EC0 (Scenedesmus quadricauda green algae) 7 days = 1,800 mg/L LC50 (Brachionus calyciflorus) 24 hours = 28,600 mg/L
EC0 (Entosiphon sulcatum protozoa) 72 hours = 4,930 mg/L LC50 (Crangon crangon brown shrimp) 48 hours = 1,400 mg/L
EC0 (Uronema parduczi Chatton-Lwoff) = 3,425 mg/L LC50 (Crangon crangon brown shrimp) 98 hours = 1,150 mg/L
EC50 (Photobacterium) 5 minutes = 22,800 mg/L LC50 (goldfish) 24 hours = > 500 mg/L
EC50 (Daphnia magna) 3,010 mg/L LC50 (fathead minnow) 1 hour = 11,830 mg/L
EC50 (Pseudomonas putida) 16 hours = 1,050 mg/L LC50 (fathead minnow) 24 hours = 11,160 mg/L
Toxic (Chlorella pyrenoidosa algae) = 17,400 mg/L LC50 (fathead minnow) 48 hours = 11,130 mg/L
NOEC (Daphnia magna) 757-2,100 mg/L LC50 (fathead minnow) 72 hours = 11,130 mg/L
LC0 (creek chub) 24 hours = 900 mg/L LC50 (fathead minnow) 96 hours = 11,130 mg/L
LC50 (Artemia salina) 24 hours = 16,700 mg/L LC50 (Poecilia reticulata guppy) 7 days = 7,060 mg/L
LC50 (Streptocephalus proboscideus) 24 hours = 11,600 mg/L LC50 (Daphnia magna) 4,600 mg/L
LC100 (creek chub) 24 hours = 1,100 mg/L
ENVIRONMENTAL EXPOSURE CONTROLS: Controls should be engineered to prevent release to the environment,
including procedures to prevent spills, atmospheric release and release to waterways.
OTHER ADVERSE EFFECTS: No component of this product is known to have ozone depletion potential.
13. DISPOSAL CONSIDERATIONS
DISPOSAL METHODS: It is the responsibility of the generator to determine at the time of disposal whether the product
meets the criteria of a hazardous waste per regulations of the area in which the waste is generated and/or disposed of.
Waste disposal must be in accordance with appropriate Federal, State, and local regulations. This product, if unaltered
by use, may be disposed of by treatment at a permitted facility or as advised by your local hazardous waste regulatory
authority. Shipment of wastes must be done with appropriately permitted and registered transporters.
BETAMETHASONE DIPROPIONATE LOTION 0.05% MSDS EFFECTIVE DATE: SEP 21, 2009
PAGE 6 OF 11
Nycomed US Inc.
13. DISPOSAL CONSIDERATIONS (Continued)
DISPOSAL CONTAINERS: Waste materials must be placed in and shipped in appropriate 5-gallon or 55-gallon poly or
metal waste pails or drums. Permeable cardboard containers are not appropriate and should not be used. Ensure that
any required marking or labeling of the containers be done to all applicable regulations.
PRECAUTIONS TO BE FOLLOWED DURING WASTE HANDLING: Wear proper protective equipment when handling
waste materials.
PREPARING WASTES FOR DISPOSAL: Waste disposal must be in accordance with appropriate U.S. Federal, State,
and local regulations or with regulations of Canada. This product, if unaltered by handling, may be disposed of by
treatment at a permitted facility or as advised by your local hazardous waste regulatory authority. All gowns, gloves,
and disposable materials used in the preparation or handling of this drug should be disposed of in accordance with
established hazardous waste disposal procedures. Handle as if capable of transmitting infectious agents.
Incineration is recommended. Reusable equipment should be cleaned with soap and water.
U.S. EPA WASTE NUMBER: Wastes of this product may need to be tested per the requirements of RCRA to determine
if such wastes meet the following characteristics: D001 (Ignitability).
14. TRANSPORTATION INFORMATION
U.S. DEPARTMENT OF TRANSPORTATION SHIPPING REGULATIONS: This product is classified as hazardous
under regulations of U.S. DOT 49 CFR 172.101. When the product meet requirements under 49 CFR ?173.144, and
requirements under 49 CFR ?173.150 (b), this product can be shipped as a Consumer Commodity, ORM-D material.
Inner packaging cannot exceed 5.0 liters (1.3 gallons), net capacity. Outer packaging cannot exceed 30 kg (66 lb gross
weight). See below (Limited Quantity Exceptions) for additional information.
Consumer Commodity
Proper Shipping Name:
ORM-D
Hazard Class Number and Description:
Not Applicable
UN Identification Number:
Not Applicable
Packing Group:
None
DOT Label(s) Required:
171
Emergency Response Guidebook Number (2008):
Marine Pollutant: No component of this product is classified by the U.S. DOT as a Marine Pollutant (as defined by 49 CFR 172.101,
Appendix B).
Limited Quantity Exceptions [49 CFR 173.150(b)]: Limited quantities for Class 3, Packing Group III materials have inner
packagings not over 5.0 liters (1.3 gallons) net capacity each, packed in strong outer packaging. The gross weight of the outer
package cannot exceed 30 kg (66 lb). Limited quantities are not subject to labeling (unless transported by air) or placarding
requirements.
When the product does not meet the requirements for classification of Consumer Quantity and ORM-D, shipments of
this product must be classified as follows:
Flammable liquids, n.o.s. (Isopropyl Alcohol)
Proper Shipping Name:
3 (Flammable)
Hazard Class Number and Description:
UN 1993
UN Identification Number:
III
Packing Group:
Class 3 (Flammable)
DOT Label(s) Required:
128
Emergency Response Guidebook Number (2008):
Small Quantity Exception (49 CFR 173.4): Small quantities of Class 3 material are not subjected to other requirements of the
Hazardous Materials Regulations (Subchapter C) when the maximum quantity per inner receptacle is limited to 30 mL (1 oz).
Refer to 49 CFR 173.4 for specific information in packaging small quantity materials.
TRANSPORT CANADA TRANSPORTATION OF DANGEROUS GOODS REGULATIONS: This product is classified
as Dangerous Goods, per regulations of Transport Canada. The use of the above U.S. DOT information from the U.S.
49 CFR regulations is allowed for shipments that originate in the U.S. For shipments via ground vehicle or rail that
originate in Canada, the following information is applicable. This product can be shipped as a Consumer Commodity,
under limited quantity exceptions as long as all requirements under Subsections 1.17(2) to (5) are met under the TDG.
Consumer commodity (Isopropyl Alcohol)
Proper Shipping Name:
Class 3 (Flammable)
Hazard Class Number and Description:
UN 1993
UN Identification Number:
Not Applicable
Packing Group:
Class 3
Hazard Label(s) Required:
16
Special Provisions:
5
Explosive Limit & Limited Quantity Index:
None
ERAP Index:
None
Passenger Carrying Ship Index:
60
Passenger Carrying Road or Rail Vehicle Index:
Marine Pollutant: No component of this product is listed as a marine pollutant, per Part 2, Section 2.7 of the Consolidated
Transportation of Dangerous Goods Regulations.
BETAMETHASONE DIPROPIONATE LOTION 0.05% MSDS EFFECTIVE DATE: SEP 21, 2009
PAGE 7 OF 11
Nycomed US Inc.
15. REGULATORY INFORMATION
UNITED STATES REGULATIONS:
U.S. SARA REPORTING REQUIREMENTS: The components of this product are subject to the reporting requirements
of Sections 302, 304, and 313 of Title III of the Superfund Amendments and Reauthorization Act, as follows:
CHEMICAL NAME SARA 302 SARA 304 SARA 313
(40 CFR 355, Appendix A) (40 CFR Table 302.4) (40 CFR 372.65)
Isopropyl Alcohol (mfg-strong acid process) No No Yes
U.S. SARA THRESHOLD PLANNING QUANTITY: There are no specific Threshold Planning Quantities for any
component of this product. The default Federal MSDS submission and inventory requirement filing threshold of 10,000
lb (4,540 kg) therefore applies, per 40 CFR 370.20.
U.S. CERCLA REPORTABLE QUANTITIES (RQ): Not applicable.
U.S. TSCA INVENTORY STATUS: This product is regulated by the Food and Drug Administration; it is not subject to
requirements under TSCA.
CALIFORNIA SAFE DRINKING WATER AND TOXIC ENFORCEMENT ACT (PROPOSITION 65): The components
of this product are not on the California Proposition 65 lists.
OTHER U.S. FEDERAL REGULATIONS: Regulatory information is available for components of this product as
follows:
ISOPROPYL ALCOHOL:
FDA: Isopropyl Alcohol is a food additive permitted for direct addition to food for human consumption, as long as 1) the quantity added to food does not exceed the
amount reasonably required to accomplish its intended physical, nutritive, or other technical effect in food, and 2) when intended for use in or on food it is of
appropriate food grade and is prepared and handled as a food ingredient. Isopropyl Alcohol may safely used as a diluent in color additive mixtures for marking food
supplements in tablet form, gum, and confectionary as long as it leaves no residues.
FIFRA: Unless designated as an active ingredient (as determined by EPA), Isopropyl Alcohol, when used in antimicrobial products as a solvent (except in tinctures or
where sole or major active ingredient) is considered inert, having no independent pesticidal activity. The percentage of such an ingredient shall be included on the
label in the total percentage of inert ingredients. Residues of Isopropyl Alcohol are exempted from the requirement of a tolerance when used as a solvent, co-solvent,
stabilizer, or inhibitor in accordance with good agricultural practice as inert (or occasionally active) ingredients in pesticide formulations applied to growing crops or to
raw agricultural commodities after harvest. Isopropyl Alcohol is exempted from the requirement of a tolerance when used as a solvent, co-solvent, stabilizer, or
inhibitor in accordance with good agricultural practice as inert (or occasionally active) ingredients in pesticide formulations applied to growing crops only. Isopropyl
Alcohol is exempted from the requirement of a tolerance when used as a solvent or co-solvent in accordance with good agricultural practice as inert (or occasionally
active) ingredients in pesticide formulations applied to animals.
ANSI LABELING (Based on 129.1, Provided to Summarize Occupational Exposure Hazards): WARNING!
FLAMMABLE LIQUID. MAY CAUSE ALLERGIC SKIN REACTION. CAUSES EYE AND RESPIRATORY TRACT
IRRITATION. MAY CAUSE SKIN IRRITATION. MAY CAUSE CENTRAL NERVOUS SYSTEM EFFECTS. Keep
away from heat, sparks, and flame. Avoid contact with skin or clothing. Do not breathe vapors. Do not taste or
swallow. Keep container closed. Use only with adequate ventilation. Wash thoroughly after handling. Wear gloves,
goggles, and appropriate body protection during handling or administration. FIRST-AID: In case of contact, flush eyes
with plenty of water. If vapors are inhaled, remove to fresh air. If adverse respiratory reaction occurs from allergic
reaction, give oxygen and seek immediate medical attention. If ingested, DO NOT induce vomiting; seek immediate
medical attention. IN CASE OF FIRE: Use water fog, dry chemical, CO2, or "alcohol" foam. IN CASE OF SPILL:
Wipe up spilled product. Place residual in appropriate container and seal. Dispose of according to applicable
regulations. Consult Material Safety Data Sheet for additional information.
CANADIAN REGULATIONS:
CANADIAN DSL/NDSL INVENTORY STATUS: This product regulated by the Therapeutic Products Programme (TPP)
of Health Canada and so it is exempt from requirements of the DSL/NDSL Inventory.
CANADIAN ENVIRONMENTAL PROTECTION ACT (CEPA) PRIORITIES SUBSTANCES LISTS: The components of
this product are not on the CEPA Priorities Substances Lists.
OTHER CANADIAN REGULATIONS: Not applicable.
CANADIAN WHMIS CLASSIFICATION AND SYMBOLS:
Class B2 Flammable Liquid
16. OTHER INFORMATION
This Material Safety Data Sheet is offered pursuant to OSHA's Hazard Communication Standard, 29 CFR, 1910.1200. Other government regulations must be reviewed for applicability to
this product. To the best of Nycomed US Inc.'s knowledge, the information contained herein is reliable and accurate as of this date; however, accuracy, suitability or completeness are
not guaranteed and no warranties of any type, either express or implied, are provided. The information contained herein relates only to this specific product. If this product is combined
with other materials, all component properties must be considered. Data may be changed from time to time. Be sure to consult the latest edition.
CHEMICAL SAFETY ASSOCIATES, Inc.
PREPARED BY:
PO Box 1961, Hilo, HI 96721
800/441-3365 ?808/969-4846
September 21, 2009
DATE OF PRINTING:
BETAMETHASONE DIPROPIONATE LOTION 0.05% MSDS EFFECTIVE DATE: SEP 21, 2009
PAGE 8 OF 11
Nycomed US Inc.
DEFINITION OF TERMS
A large number of abbreviations and acronyms appear on a MSDS. Some of these, which are commonly used, include the following:
CAS #: This is the Chemical Abstract Service Number that uniquely identifies each HAZARDOUS MATERIALS IDENTIFICATION SYSTEM HAZARD
constituent. RATINGS (continued):
EXPOSURE LIMITS IN AIR: HEALTH HAZARD (continued): 3 (continued): Oral Toxicity LD50 Rat: > 1?0 mg/kg.
CEILING LEVEL: The concentration that shall not be exceeded during any part of the Dermal Toxicity LD50 Rat or Rabbit: > 20?00 mg/kg. Inhalation Toxicity LC50 4-hrs Rat:
working exposure. > 0.05?.5 mg/L. 4 Severe Hazard: Life-threatening; major or permanent damage may
DFG MAK Germ Cell Mutagen Categories: 1: Germ cell mutagens that have been result from single or repeated exposures; extremely toxic; irreversible injury may result
shown to increase the mutant frequency in the progeny of exposed humans. 2: Germ from brief contact. Skin Irritation: Not appropriate. Do not rate as a 4, based on skin
cell mutagens that have been shown to increase the mutant frequency in the progeny of irritation alone. Eye Irritation: Not appropriate. Do not rate as a 4, based on eye irritation
exposed mammals. 3A: Substances that have been shown to induce genetic damage in alone. Oral Toxicity LD50 Rat: 1 mg/kg. Dermal Toxicity LD50 Rat or Rabbit: 20 mg/kg.
germ cells of human of animals, or which produce mutagenic effects in somatic cells of Inhalation Toxicity LC50 4-hrs Rat: 0.05 mg/L.
mammals in vivo and have been shown to reach the germ cells in an active form. 3B: FLAMMABILITY HAZARD: 0 Minimal Hazard: Materials that will not burn in air when
Substances that are suspected of being germ cell mutagens because of their genotoxic exposure to a temperature of 815.5癈 (1500癋) for a period of 5 minutes. 1 Slight
effects in mammalian somatic cell in vivo; in exceptional cases, substances for which Hazard: Materials that must be pre-heated before ignition can occur. Material requires
there are no in vivo data, but that are clearly mutagenic in vitro and structurally related to considerable pre-heating, under all ambient temperature conditions before ignition and
known in vivo mutagens. 4: Not applicable (Category 4 carcinogenic substances are combustion can occur. This usually includes the following: Materials that will burn in air
those with non-genotoxic mechanisms of action. By definition, germ cell mutagens are when exposed to a temperature of 815.5癈 (1500癋) for a period of 5 minutes or less;
genotoxic. Therefore, a Category 4 for germ cell mutagens cannot apply. At some time in Liquids, solids and semisolids having a flash point at or above 93.3癈 (200癋) (i.e.
the future, it is conceivable that a Category 4 could be established for genotoxic OSHA Class IIIB); and Most ordinary combustible materials (e.g. wood, paper, etc.). 2
substances with primary targets other than DNA [e.g. purely aneugenic substances] if Moderate Hazard: Materials that must be moderately heated or exposed to relatively
research results make this seem sensible.) 5: Germ cell mutagens, the potency of which high ambient temperatures before ignition can occur. Materials in this degree would not,
is considered to be so low that, provided the MAK value is observed, their contribution to under normal conditions, form hazardous atmospheres in air, but under high ambient
genetic risk for humans is expected not to be significant. temperatures or moderate heating may release vapor in sufficient quantities to produce
DFG MAK Pregnancy Risk Group Classification: Group A: A risk of damage to the hazardous atmospheres with air. This usually includes the following: Liquids having a
developing embryo or fetus has been unequivocally demonstrated. Exposure of pregnant flash-point at or above 37.8癈 (100癋); Solid materials in the form of course dusts that
women can lead to damage of the developing organism, even when MAK and BAT may burn rapidly but that generally do not form explosive atmospheres; Solid materials
(Biological Tolerance Value for Working Materials) values are observed. Group B: in a fibrous or shredded form that may burn rapidly and create flash fire hazards (e.g.
Currently available information indicates a risk of damage to the developing embryo or cotton, sisal, hemp); and Solids and semisolids (e.g. viscous and slow flowing as
fetus must be considered to be probable. Damage to the developing organism cannot be asphalt) that readily give off flammable vapors. 3 Serious Hazard: Liquids and solids that
excluded when pregnant women are exposed, even when MAK and BAT values are can be ignited under almost all ambient temperature conditions. Materials in this degree
observed. Group C: There is no reason to fear a risk of damage to the developing produce hazardous atmospheres with air under almost all ambient temperatures, or,
embryo or fetus when MAK and BAT values are observed. Group D: Classification in unaffected by ambient temperature, are readily ignited under almost all conditions. This
one of the groups A瑿 is not yet possible because, although the data available may usually includes the following: Liquids having a flash point below 22.8癈 (73癋) and
indicate a trend, they are not sufficient for final evaluation. having a boiling point at or above 38癈 (100癋) and those liquids having a flash point at
IDLH: Immediately Dangerous to Life and Health. This level represents a concentration or above 22.8癈 (73癋) and below 37.8癈 (100癋) (i.e. OSHA Class IB and IC);
from which one can escape within 30-minutes without suffering escape-preventing or Materials that on account of their physical form or environmental conditions can form
permanent injury. explosive mixtures with air and are readily dispersed in air (e.g., dusts of combustible
LOQ: Limit of Quantitation. solids, mists or droplets of flammable liquids); and Materials that burn extremely rapidly,
MAK: Federal Republic of Germany Maximum Concentration Values in the workplace. usually by reason of self-contained oxygen (e.g. dry nitrocellulose and many organic
NE: Not Established. When no exposure guidelines are established, an entry of NE is peroxides). 4 Severe Hazard: Life-threatening; major or permanent damage may result
made for reference. from single or repeated exposures; extremely toxic; irreversible injury may result from
NIC: Notice of Intended Change. brief contact. Skin Irritation: Not appropriate. Do not rate as a 4, based on skin irritation
NIOSH CEILING: The exposure that shall not be exceeded during any part of the alone. Eye Irritation: Not appropriate. Do not rate as a 4, based on eye irritation alone.
workday. If instantaneous monitoring is not feasible, the ceiling shall be assumed as a Oral Toxicity LD50 Rat: 1 mg/kg. Dermal Toxicity LD50 Rat or Rabbit: 20 mg/kg.
15-minute TWA exposure (unless otherwise specified) that shall not be exceeded at any Inhalation Toxicity LC50 4-hrs Rat: 0.05 mg/L.
time during a workday. FLAMMABILITY HAZARD: 0 Minimal Hazard: Materials that will not burn in air when
NIOSH RELs: NIOSH's Recommended Exposure Limits. exposure to a temperature of 815.5癈 (1500癋) for a period of 5 minutes. 1 Slight
PEL: OSHA's Permissible Exposure Limits. This exposure value means exactly the Hazard: Materials that must be pre-heated before ignition can occur. Material requires
same as a TLV, except that it is enforceable by OSHA. The OSHA Permissible considerable pre-heating, under all ambient temperature conditions before ignition and
Exposure Limits are based in the 1989 PELs and the June, 1993 Air Contaminants Rule combustion can occur. This usually includes the following: Materials that will burn in air
(Federal Register: 58: 35338-35351 and 58: 40191). Both the current PELs and the when exposed to a temperature of 815.5癈 (1500癋) for a period of 5 minutes or less;
vacated PELs are indicated. The phrase, "Vacated 1989 PEL" is placed next to the PEL Liquids, solids and semisolids having a flash point at or above 93.3癈 (200癋) (i.e.
that was vacated by Court Order. OSHA Class IIIB); and Most ordinary combustible materials (e.g. wood, paper, etc.). 2
SKIN: Used when a there is a danger of cutaneous absorption. Moderate Hazard: Materials that must be moderately heated or exposed to relatively
STEL: Short Term Exposure Limit, usually a 15-minute time-weighted average (TWA) high ambient temperatures before ignition can occur. Materials in this degree would not,
exposure that should not be exceeded at any time during a workday, even if the 8-hr under normal conditions, form hazardous atmospheres in air, but under high ambient
TWA is within the TLV-TWA, PEL-TWA or REL-TWA. temperatures or moderate heating may release vapor in sufficient quantities to produce
TLV: Threshold Limit Value. An airborne concentration of a substance that represents hazardous atmospheres with air. This usually includes the following: Liquids having a
conditions under which it is generally believed that nearly all workers may be repeatedly flash-point at or above 37.8癈 (100癋); Solid materials in the form of course dusts that
exposed without adverse effect. The duration must be considered, including the 8-hour. may burn rapidly but that generally do not form explosive atmospheres; Solid materials
TWA: Time Weighted Average exposure concentration for a conventional 8-hr (TLV, in a fibrous or shredded form that may burn rapidly and create flash fire hazards (e.g.
PEL) or up to a 10-hr (REL) workday and a 40-hr workweek. cotton, sisal, hemp); and Solids and semisolids (e.g. viscous and slow flowing as
WEEL: Workplace Environmental Exposure Limits from the AIHA. asphalt) that readily give off flammable vapors. 3 Serious Hazard: Liquids and solids that
HAZARDOUS MATERIALS IDENTIFICATION SYSTEM HAZARD can be ignited under almost all ambient temperature conditions. Materials in this degree
produce hazardous atmospheres with air under almost all ambient temperatures, or,
RATINGS: This rating system was developed by the National Paint and Coating
unaffected by ambient temperature, are readily ignited under almost all conditions. This
Association and has been adopted by industry to identify the degree of chemical
usually includes the following: Liquids having a flash point below 22.8癈 (73癋) and
hazards.
having a boiling point at or above 38癈 (100癋) and those liquids having a flash point at
HEALTH HAZARD: 0 Minimal Hazard: No significant health risk, irritation of skin or eyes
or above 22.8癈 (73癋) and below 37.8癈 (100癋) (i.e. OSHA Class IB and IC);
not anticipated. Skin Irritation: Essentially non-irritating. Mechanical irritation may occur.
Materials that on account of their physical form or environmental conditions can form
PII or Draize = 0. Eye Irritation: Essentially non-irritating, minimal effects clearing in < 24
explosive mixtures with air and are readily dispersed in air (e.g., dusts of combustible
hours. Mechanical irritation may occur. Draize = 0. Oral Toxicity LD50 Rat: > 5000 mg/kg.
solids, mists or droplets of flammable liquids); and Materials that burn extremely rapidly,
Dermal Toxicity LD50 Rat or Rabbit: > 2000 mg/kg. Inhalation Toxicity 4-hrs LC50 Rat: >
usually by reason of self-contained oxygen (e.g. dry nitrocellulose and many organic
20 mg/L. 1 Slight Hazard: Minor reversible injury may occur; may irritate the stomach if
peroxides). 4 Severe Hazard: Materials that will rapidly or completely vaporize at
swallowed; may defat the skin and exacerbate existing dermatitis. Skin Irritation: Slightly
atmospheric pressure and normal ambient temperature or that are readily dispersed in
or mildly irritating. PII or Draize > 0 < 5. Eye Irritation: Slightly to mildly irritating, but
air, and that will burn readily. This usually includes the following: Flammable gases;
reversible within 7 days. Draize > 0 25. Oral Toxicity LD50 Rat: > 500?000 mg/kg.
Flammable cryogenic materials; Any liquid or gaseous material that is liquid while under
Dermal Toxicity LD50 Rat or Rabbit: > 1000?000 mg/kg. Inhalation Toxicity LC50 4-hrs
pressure and has a flash point below 22.8癈 (73癋) and a boiling point below 37.8癈
Rat: > 2?0 mg/L. 2 Moderate Hazard: Temporary or transitory injury may occur;
(100癋) (i.e. OSHA Class IA); and Materials that ignite spontaneously when exposed to
prolonged exposure may affect the CNS. Skin Irritation: Moderately irritating; primary
air at a temperature of 54.4癈 (130癋) or below (pyrophoric).
irritant; sensitizer. PII or Draize 5, with no destruction of dermal tissue. Eye Irritation:
PHYSICAL HAZARD: 0 Water Reactivity: Materials that do not react with water. Organic
Moderately to severely irritating; reversible corneal opacity; corneal involvement or
Peroxides: Materials that are normally stable, even under fire conditions and will not
irritation clearing in 8?1 days. Draize = 26?00, with reversible effects. Oral Toxicity
react with water. Explosives: Substances that are Non-Explosive. Compressed Gases:
LD50 Rat: > 50?00 mg/kg. Dermal Toxicity LD50 Rat or Rabbit: > 200?000 mg/kg.
No Rating. Pyrophorics: No Rating. Oxidizers: No 0 rating. Unstable Reactives:
Inhalation Toxicity LC50 4-hrs Rat: > 0.5? mg/L. 3 Serious Hazard: Major injury likely
Substances that will not polymerize, decompose, condense, or self-react). 1 Water
unless prompt action is taken and medical treatment is given; high level of toxicity;
Reactivity: Materials that change or decompose upon exposure to moisture. Organic
corrosive. Skin Irritation: Severely irritating and/or corrosive; may cause destruction of
Peroxides: Materials that are normally stable, but can become unstable at high
dermal tissue, skin burns, and dermal necrosis. PII or Draize > 5?, with destruction of
temperatures and pressures. These materials may react with water, but will not release
tissue. Eye Irritation: Corrosive, irreversible destruction of ocular tissue; corneal
energy violently.
involvement or irritation persisting for more than 21 days. Draize > 80 with effects
irreversible in 21 days.
BETAMETHASONE DIPROPIONATE LOTION 0.05% MSDS EFFECTIVE DATE: SEP 21, 2009
PAGE 9 OF 11
Nycomed US Inc.
DEFINITION OF TERMS (Continued)
HAZARDOUS MATERIALS IDENTIFICATION SYSTEM HAZARD NATIONAL FIRE PROTECTION ASSOCIATION HAZARD RATINGS
RATINGS (continued): (continued):
PHYSICAL HAZARD (continued): 1 (continued): Explosives: Division 1.5 & 1.6 HEALTH HAZARD (continued):3 (continued): Materials that are corrosive to the
explosives. Substances that are very insensitive explosives or that do not have a mass respiratory tract. Materials that are corrosive to the eyes or cause irreversible corneal
explosion hazard. Compressed Gases: Pressure below OSHA definition. Pyrophorics: opacity. Materials corrosive to the skin. Cryogenic gases that cause frostbite and
No Rating. Oxidizers: Packaging Group III oxidizers; Solids: any material that in either irreversible tissue damage. Compressed liquefied gases with boiling points below -55癈
concentration tested, exhibits a mean burning time less than or equal to the mean (-66.5癋) that cause frostbite and irreversible tissue damage. Materials with an LD50 for
acute oral toxicity greater than 5 mg/kg but less than or equal to 50 mg/kg. 4 Materials
burning time of a 3:7 potassium bromate/cellulose mixture and the criteria for Packing
Group I and II are not met. Liquids: any material that exhibits a mean pressure rise time that, under emergency conditions, can be lethal. Gases with an LC50 for acute inhalation
less than or equal to the pressure rise time of a 1:1 nitric acid (65%)/cellulose mixture toxicity less than or equal to 1,000 ppm. Any liquid whose saturated vapor concentration
and the criteria for Packing Group I and II are not met. Unstable Reactives: Substances at 20癈 (68癋) is equal to or greater than ten times its LC50 for acute inhalation toxicity, if
that may decompose condense, or self-react, but only under conditions of high its LC50 is less than or equal to 1000 ppm. Dusts and mists whose LC50 for acute
temperature and/or pressure and have little or no potential to cause significant heat inhalation toxicity is less than or equal to 0.5 mg/L. Materials whose LD50 for acute
generation or explosion hazard. Substances that readily undergo hazardous dermal toxicity is less than or equal to 40 mg/kg. Materials whose LD50 for acute oral
polymerization in the absence of inhibitors. Substances that readily undergo hazardous toxicity is less than or equal to 5 mg/kg.
polymerization in the absence of inhibitors. 2 Water Reactivity: Materials that may react FLAMMABILITY HAZARD: 0 Materials that will not burn under typical fire conditions,
violently with water. Organic Peroxides: Materials that, in themselves, are normally including intrinsically noncombustible materials such as concrete, stone, and sand.
unstable and will readily undergo violent chemical change, but will not detonate. These Materials that will not burn in air when exposed to a temperature of 816癈 (1500癋) for a
period of 5 minutes in according with Annex D of NFPA 704. 1 Materials that must be
materials may also react violently with water. Explosives: Division 1.4 explosives.
Explosive substances where the explosive effects are largely confined to the package preheated before ignition can occur. Materials in this degree require considerable
and no projection of fragments of appreciable size or range are expected. An external preheating, under all ambient temperature conditions, before ignition and combustion
fire must not cause virtually instantaneous explosion of almost the entire contents of the can occur: Materials that will burn in air when exposed to a temperature of 816癈
package. Compressed Gases: Pressurized and meet OSHA definition but < 514.7 psi (1500癋) for a period of 5 minutes in according with Annex D of NFPA 704. Liquids,
absolute at 21.1癈 (70癋) [500 psig]. Pyrophorics: No Rating. Oxidizers: Packing Group solids, and semisolids having a flash point at or above 93.4癈 (200癋) (i.e. Class IIIB
II oxidizers. Solids: any material that, either in concentration tested, exhibits a mean liquids). Liquids with a flash point greater than 35癈 (95癋) that do not sustain
burning time of less than or equal to the mean burning time of a 2:3 potassium combustion when tested using the Method of Testing for Sustained Combustibility, per
bromate/cellulose mixture and the criteria for Packing Group I are not met. Reactives: 49 CFR 173, Appendix H or the UN Recommendations on the Transport of Dangerous
Substances that may polymerize, decompose, condense, or self-react at ambient Goods, Model Regulations (current edition) and the related Manual of Tests and Criteria
temperature and/or pressure, but have a low potential (or low risk) for significant heat (current edition). Liquids with a flash point greater than 35癈 (95癋) in a water-miscible
generation or explosion. Substances that readily form peroxides upon exposure to air or solution or dispersion with a water non-combustible liquid/solid content of more than
oxygen at room temperature. 3 Water Reactivity: Materials that may form explosive 85% by weight. Liquids that have no fire point when tested by ASTM D 92, Standard
reactions with water. Organic Peroxides: Materials that are capable of detonation or Test Method for Flash and Fire Points by Cleveland Open Cup, up to the boiling point of
explosive reaction, but require a strong initiating source or must be heated under the liquid or up to a temperature at which the sample being tested shows an obvious
confinement before initiation; or materials that react explosively with water. Explosives: physical change. Combustible pellets with a representative diameter of greater than 2
Division 1.3 explosives. Explosive substances that have a fire hazard and either a minor mm (10 mesh). Most ordinary combustible materials. Solids containing greater than
blast hazard or a minor projection hazard or both, but do not have a mass explosion 0.5% by weight of a flammable or combustible solvent are rated by the closed cup flash
point of the solvent. 2 Materials that must be moderately heated or exposed to relatively
hazard. Compressed Gases: Pressure 514.7 psi absolute at 21.1癈 (70癋) [500 psig].
Pyrophorics: No Rating. Oxidizers: Packing Group I oxidizers. Solids: any material that, high ambient temperatures before ignition can occur. Materials in this degree would not
in either concentration tested, exhibits a mean burning time less than the mean burning under normal conditions form hazardous atmospheres with air, but under high ambient
time of a 3:2 potassium bromate/cellulose mixture. Liquids: any material that temperatures or under moderate heating could release vapor in sufficient quantities to
spontaneously ignites when mixed with cellulose in a 1:1 ratio, or which exhibits a mean produce hazardous atmospheres with air. Liquids having a flash point at or above 37.8癈
pressure rise time less than the pressure rise time of a 1:1 perchloric acid (100癋) and below 93.4癈 (200癋) (i.e. Class II and Class IIIA liquids.) Solid materials in
(50%)/cellulose mixture. Unstable Reactives: Substances that may polymerize, the form of powders or coarse dusts of representative diameter between 420 microns
decompose, condense, or self-react at ambient temperature and/or pressure and have a (40 mesh) and 2 mm (10 mesh) that burn rapidly but that generally do not form explosive
moderate potential (or moderate risk) to cause significant heat generation or explosion. 4 mixtures with air. Solid materials in fibrous or shredded form that burn rapidly and create
Water Reactivity: Materials that react explosively with water without requiring heat or flash fire hazards, such as cotton, sisal, and hemp. Solids and semisolids that readily
confinement. Organic Peroxides: Materials that are readily capable of detonation or give off flammable vapors. Solids containing greater than 0.5% by weight of a flammable
or combustible solvent are rated by the closed cup flash point of the solvent. 3 Liquids
explosive decomposition at normal temperature and pressures. Explosives: Division 1.1
& 1.2 explosives. Explosive substances that have a mass explosion hazard or have a and solids that can be ignited under almost all ambient temperature conditions. Materials
projection hazard. A mass explosion is one that affects almost the entire load in this degree produce hazardous atmospheres with air under almost all ambient
instantaneously. Compressed Gases: No Rating. Pyrophorics: Add to the definition of temperatures or, though unaffected by ambient temperatures, are readily ignited under
Flammability 4. Oxidizers: No 4 rating. Unstable Reactives: Substances that may almost all conditions. Liquids having a flash point below 22.8癈 (73癋) and having a
polymerize, decompose, condense, or self-react at ambient temperature and/or pressure boiling point at or above 37.8癈 (100癋) and those liquids having a flash point at or
and have a high potential (or high risk) to cause significant heat generation or explosion. above 22.8癈 (73癋) and below 37.8癈 (100癋) (i.e. Class IB and IC liquids). Materials
that on account of their physical form or environmental conditions can form explosive
NATIONAL FIRE PROTECTION ASSOCIATION HAZARD RATINGS:
mixtures with air and are readily dispersed in air. Flammable or combustible dusts with
HEALTH HAZARD: 0 Materials that, under emergency conditions, would offer no hazard
representative diameter less than 420 microns (40 mesh). Materials that burn with
beyond that of ordinary combustible materials. Gases and vapors with an LC50 for acute
extreme rapidity, usually by reason of self-contained oxygen (e.g. dry nitrocellulose and
inhalation toxicity greater than 10,000 ppm. Dusts and mists with an LC50 for acute
many organic peroxides). Solids containing greater than 0.5% by weight of a flammable
inhalation toxicity greater than 200 mg/L. Materials with an LD50 for acute dermal toxicity
or combustible solvent are rated by the closed cup flash point of the solvent. 4 Materials
greater than 2000 mg/kg. Materials with an LD50 for acute oral toxicity greater than 2000
that will rapidly or completely vaporize at atmospheric pressure and normal ambient
mg/kg. Materials essentially non-irritating to the respiratory tract, eyes, and skin. 1
temperature or that are readily dispersed in air and will burn readily. Flammable gases.
Materials that, under emergency conditions, can cause significant irritation. Gases and
Flammable cryogenic materials. Any liquid or gaseous materials that is liquid while under
vapors with an LC50 for acute inhalation toxicity greater than 5,000 ppm but less than or
pressure and has a flash point below 22.8癈 (73癋) and a boiling point below 37.8癈
equal to 10,000 ppm. Dusts and mists with an LC50 for acute inhalation toxicity greater
(100癋) (i.e. Class IA liquids). Materials that ignite when exposed to air, Solids containing
than 10 mg/L but less than or equal to 200 mg/L. Materials with an LD50 for acute dermal
greater than 0.5% by weight of a flammable or combustible solvent are rated by the
toxicity greater than 1000 mg/kg but less than or equal to 2000 mg/kg. Materials that
closed cup flash point of the solvent.
slightly to moderately irritate the respiratory tract, eyes and skin. Materials with an LD50
INSTABILITY HAZARD: 0 Materials that in themselves are normally stable, even under
for acute oral toxicity greater than 500 mg/kg but less than or equal to 2000 mg/kg. 2
fire conditions. Materials that have an instantaneous power density (product of heat of
Materials that, under emergency conditions, can cause temporary incapacitation or
reaction and reaction rate) at 250癈 (482癋) below 0.01 W/mL. Materials that do not
residual injury. Gases with an LC50 for acute inhalation toxicity greater than 3,000 ppm
exhibit an exotherm at temperatures less than or equal to 500癈 (932癋) when tested by
but less than or equal to 5,000 ppm. Any liquid whose saturated vapor concentration at
differential scanning calorimetry. 1 Materials that in themselves are normally stable, but
20癈 (68癋) is equal to or greater than one-fifth its LC50 for acute inhalation toxicity, if its
that can become unstable at elevated temperatures and pressures. Materials that have
LC50 is less than or equal to 5000 ppm and that does not meet the criteria for either
an instantaneous power density (product of heat of reaction and reaction rate) at 250癈
degree of hazard 3 or degree of hazard 4. Dusts and mists with an LC50 for acute
(482癋) at or above 0.01 W/mL and below 10 W/mL. 2 Materials that readily undergo
inhalation toxicity greater than 2 mg/L but less than or equal to 10 mg/L. Materials with
violent chemical change at elevated temperatures and pressures. Materials that have an
an LD50 for acute dermal toxicity greater than 200 mg/kg but less than or equal to 1000
instantaneous power density (product of heat of reaction and reaction rate) at 250癈
mg/kg. Compressed liquefied gases with boiling points between -30癈 (-22癋) and -55癈
(482癋) at or above 10 W/mL and below 100W/mL. 3 Materials that in themselves are
(-66.5癋) that cause severe tissue damage, depending on duration of exposure.
capable of detonation or explosive decomposition or explosive reaction, but that require
Materials that are respiratory irritants. Materials that cause severe, but reversible
a strong initiating source or that must be heated under confinement before initiation.
irritation to the eyes or are lachrymators. Materials that are primary skin irritants or
Materials that have an estimated instantaneous power density (product of heat of
sensitizers. Materials whose LD50 for acute oral toxicity is greater than 50 mg/kg but less
reaction and reaction rate) at 250癈 (482癋) at or above 100 W/mL and below 1000
than or equal to 500 mg/kg. 3 Materials that, under emergency conditions, can cause
W/mL. Materials that are sensitive to thermal or mechanical shock at elevated
serious or permanent injury. Gases with an LC50 for acute inhalation toxicity greater than
temperatures and pressures. 4 Materials that in themselves are readily capable of
1,000 ppm but less than or equal to 3,000 ppm. Any liquid whose saturated vapor
detonation or explosive decomposition or explosive reaction at normal temperatures and
concentration at 20癈 (68癋) is equal to or greater its LC50 for acute inhalation toxicity, if
pressures. Materials that are sensitive to localized thermal or mechanical shock at
its LC50 is less than or equal to 3000 ppm and that does not meet the criteria for degree
normal temperatures and pressures. Materials that have an estimated instantaneous
of hazard 4. Dusts and mists with an LC50 for acute inhalation toxicity greater than 0.5
power density (product of heat of reaction and reaction rate) at 250癈 (482癋) of 1000
mg/L but less than or equal to 2 mg/L. Materials with an LD50 for acute dermal toxicity
W/mL or greater.
greater than 40 mg/kg but less than or equal to 200 mg/kg.
BETAMETHASONE DIPROPIONATE LOTION 0.05% MSDS EFFECTIVE DATE: SEP 21, 2009
PAGE 10 OF 11
Nycomed US Inc.
DEFINITION OF TERMS (Continued)
FLAMMABILITY LIMITS IN AIR: ECOLOGICAL INFORMATION:
Much of the information related to fire and explosion is derived from the National Fire EC: Effect concentration in water. BCF: Bioconcentration Factor, which is used to
Protection Association (NFPA). Flash Point: Minimum temperature at which a liquid determine if a substance will concentrate in life forms that consume contaminated plant
gives off sufficient vapor to form an ignitable mixture with air near the surface of the or animal matter. TLm: Median threshold limit. log KOW or log KOC: Coefficient of
liquid or within the test vessel used. Autoignition Temperature: Minimum temperature of Oil/Water Distribution is used to assess a substance's behavior in the environment.
a solid, liquid, or gas required to initiate or cause self-sustained combustion in air with no REGULATORY INFORMATION:
other source of ignition. LEL: Lowest concentration of a flammable vapor or gas/air U.S.:
mixture that will ignite and burn with a flame. UEL: Highest concentration of a flammable EPA: U.S. Environmental Protection Agency. ACGIH: American Conference of
vapor or gas/air mixture that will ignite and burn with a flame. Governmental Industrial Hygienists, a professional association that establishes exposure
TOXICOLOGICAL INFORMATION: limits. OSHA: U.S. Occupational Safety and Health Administration. NIOSH: National
Human and Animal Toxicology: Possible health hazards as derived from human data, Institute of Occupational Safety and Health, which is the research arm of OSHA. DOT:
animal studies, or from the results of studies with similar compounds are presented. U.S. Department of Transportation. TC: Transport Canada. SARA: Superfund
LD50: Lethal Dose (solids & liquids) that kills 50% of the exposed animals. LC50: Lethal Amendments and Reauthorization Act. TSCA: U.S. Toxic Substance Control Act.
Concentration (gases) that kills 50% of the exposed animals. ppm: Concentration CERCLA: Comprehensive Environmental Response, Compensation, and Liability Act.
expressed in parts of material per million parts of air or water. mg/m3: Concentration Marine Pollutant status according to the DOT; CERCLA or Superfund; and various state
expressed in weight of substance per volume of air. mg/kg: Quantity of material, by regulations. This section also includes information on the precautionary warnings that
weight, administered to a test subject, based on their body weight in kg. TDLo: Lowest appear on the material's package label.
dose to cause a symptom. TCLo: Lowest concentration to cause a symptom. TDo, LDLo, CANADA:
and LDo, or TC, TCo, LCLo, and LCo: Lowest dose (or concentration) to cause lethal or WHMIS: Canadian Workplace Hazardous Materials Information System. TC: Transport
toxic effects. Canada. DSL/NDSL: Canadian Domestic/Non-Domestic Substances List.
Cancer Information: IARC: International Agency for Research on Cancer. NTP:
National Toxicology Program. RTECS: Registry of Toxic Effects of Chemical
Substances. IARC and NTP rate chemicals on a scale of decreasing potential to cause
human cancer with rankings from 1 to 4. Subrankings (2A, 2B, etc.) are also used. Other
Information: BEI: ACGIH Biological Exposure Indices, represent the levels of
determinants which are most likely to be observed in specimens collected from a healthy
worker who has been exposed to chemicals to the same extent as a worker with
inhalation exposure to the TLV.
BETAMETHASONE DIPROPIONATE LOTION 0.05% MSDS EFFECTIVE DATE: SEP 21, 2009
PAGE 11 OF 11
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